American Heart Association

American Heart Association

November 18, 2019
3 min read
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ED visits spike, prescribing patterns change in wake of valsartan recall

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PHILADELPHIA — When multiple generic valsartan products were recalled worldwide in July 2018 due to the presence of a carcinogenic contaminant, valsartan dispensing immediately decreased. However, there was an immediate spike in ED visits for hypertension and incomplete replacement with alternative products in some patients, according to new data presented at the American Heart Association Scientific Sessions.

Researchers aimed to characterize changes in prescription patterns in users of recalled valsartan products before and after the July 2018 recall date. Analysis of multiple linked healthcare databases yielded 55,461 patients who were dispensed a supply of at least one recalled valsartan product.

Within 1 month of the recall, 74% of patients switched to a non-valsartan angiotensin receptor antagonist or a non-recalled valsartan product (9%), and 84% filled a new prescription for an alternative to the recalled valsartan. However, at 3 months, 10.7% of recalled valsartan users did not fill a prescription for an alternative medication, Cynthia Jackevicius, BScPhm, PharmD, MSc, FCSHP, BCPS, professor in the College of Pharmacy at the Western University of Health Sciences, Pomona, California, said during a presentation.

Immediately following the recall, ED visits for hypertension jumped by 55% compared with pre-recall ED visits, from 0.11% per month before July 2018 to 0.17% per month after the recall (P = .02). ED visits for hypertension decreased in the subsequent months following the recall (P = .02). There was no change in hospitalizations for hypertension, according to the results.

ED visits or hospitalizations for stroke and transient ischemic attack did not change in the wake of the recall, but the researchers observed an increasing temporal trend in ED visits of 6% (P = .02) and hospitalizations of 8% (P = .037) after July 2018.

When multiple generic valsartan products were recalled worldwide in July 2018 due to the presence of a carcinogenic contaminant, valsartan dispensing immediately decreased. However, there was an immediate spike in ED visits for hypertension and incomplete replacement with alternative products in some patients.
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“It is uncertain whether the increased ED visits simply reflect excess health care utilization by patients seeking replacement prescriptions for their recalled valsartan, or encounters for loss of hypertension control,” Jackevicius and colleagues wrote in a research letter published in Circulation.

As Healio previously reported, the widespread recall was initially due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the active pharmaceutical ingredient of some generic valsartan-containing medications. NDMA is classified as a probable human carcinogen based on laboratory test results. During the FDA’s subsequent investigation of these products, scientists found a second impurity, N-nitrosodiethylamine (NDEA), which has been found in some irbesartan and losartan products. Earlier this year, the FDA provided information about a third impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), found in certain losartan products.

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The global investigation into nitrosamine impurities in angiotensin receptor blockers is ongoing.

“There was a very prompt response and a lot of immediate efforts by people worried about this and wanted to act on the situation. However, there were some unintended consequences,” Jackevicius said during the presentation. “There was incomplete replacement, and 1 in 10 patients who were prescribed [recalled valsartan] didn't fill an alternative prescription. Whether that’s because patients intentionally did not fill or there was unintentional nonadherence or confusion, there are some potential concerns. It is possible patients may have also just increased another antihypertensives they were taking to compensate, but it is concerning regardless that at 10% of patients did not have a new prescription.”

In this cohort, the mean age was 76 years, 42% were men, 95% had hypertension and 5% had HF.

“I think we can do better,” Jackevicius said during the presentation. “Patients shouldn't have to go to the ED to get a new prescription to replace the one that was recalled. We need to have a better system where patients can — more easily, and with less burden — deal with a recall. Recalls are increasing after this and recalls are continuing. We need to think about better systems and more efficient ways to handle recalls so it is less stressful for patients.” – by Scott Buzby

References:

Jackevicius C, et al. Featured Science: Population Science. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.

Jackevicius C, et al. Circulation. 2019;doi:10.1161/CIRCULATIONAHA.119.044494.

Disclosures: Jackevicius is associate editor of Circulation: Cardiovascular Quality and Outcomes. Please see the full study for the authors’ relevant financial disclosures.